Let's K-Talk - HPV Study for Ethnic Koreans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2026-07-31

Brief Summary

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The goal of this clinical trial is to test the feasibility, acceptability, and preliminary efficacy of a storytelling video-based intervention using AI chatbot technology (K-Talk) to promote HPV vaccination behavior among Korean Americans aged 18 to 45.

The main questions this study aims to answer are:

* Is the K-Talk intervention feasible for use among Korean Americans aged 18 to 45?
* Is the K-Talk intervention acceptable to the target population?
* What is the preliminary efficacy of the K-Talk intervention in promoting HPV vaccination uptake?

Participants will be Korean Americans aged 18 to 45 who are at risk for HPV infection. Participants will be asked to complete a baseline survey and then will be "randomized" into one of four groups: Group 1 (chatbot + storytelling intervention), Group 2 (chatbot only), Group 3 (storytelling only), and Group 4 will be only exposed to written didactic HPV education materials. All groups will receive written didactic HPV education materials. Researchers will compare how Group 1, a combination of AI Chatbot and storytelling intervention is more effective than other intervention groups in promoting HPV vaccination uptake among underserved, hard-to-reach Korean Americans.

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Detailed Description

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The objective of this study is to conduct a pilot Multiphase Optimization Strategy trial (MOST) to evaluate the acceptability, feasibility, and preliminary efficacy of K-Talk as an intervention to improve HPV vaccination initiation and completion among Korean American men and women. K-Talk is a user-centered intervention that combines AI chatbot technology with storytelling to enhance health communication, foster connection, and provide accurate advice related to HPV vaccination. The study design follows an optimization phase of the MOST, utilizing a 2 x 2 factorial design with two factors (storytelling and chatbot) and two levels (Yes/On and No/Off). The study aims to recruit a total of 160 participants, with 40 participants assigned to each experimental condition. The sample will consist of 80 males and 80 females who are eligible for participation in factorial experimentation using the MOST design. Interested individuals will undergo an online eligibility screening survey. If eligible for the study, participants will receive an online survey link containing informed consent, a baseline survey, written HPV information, and random assignment to an intervention group.

Conditions

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Human Papillomavirus Viruses Papillomavirus Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Participants will be randomized to one of four experimental conditions using a 2x2 factorial design with two factors (Storytelling and Chatbot) and two levels (Yes/On and No/Off). Acceptability and feasibility outcomes include recruitment/retention rates, obtaining photographic documentation, and perceived satisfaction with the intervention.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Qualtrics is an online survey software used by researchers. It can randomly assign participants to different groups without revealing the assignments to participants or researchers, blinding them to the assignment. This ensures unbiased treatment and assessment of participants.

Study Groups

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K-Talk Intervention: Storytelling and AI Chatbot

After completing the pre-test survey, participants from all intervention groups will receive the written information. Subsequently, they will be randomly assigned to one of the intervention groups. The K-Talk group will receive a series of weekly storytelling videos, and access to the chatbot via the web-based platform KakaoTalk for 3 months.

Group Type EXPERIMENTAL

K-Talk Intervention (Storytelling and K-Bot)

Intervention Type OTHER

The K-Talk intervention group receives a combination of a storytelling intervention and an artificial intelligence chatbot (K-Bot) education.

Written Information

Intervention Type OTHER

The written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines.

Storytelling Intervention

After completing the pre-test survey, participants from all intervention groups will receive the written information. Subsequently, they will be randomly assigned to one of the intervention groups. The storytelling intervention group will only be exposed to periodic release of stories via email for 3 months.

Group Type EXPERIMENTAL

Storytelling Intervention

Intervention Type OTHER

The storytelling intervention features 12 authentic stories from young Korean immigrants and Americans. Each video is about 3 minutes long and includes stories from 1st, 1.5, and 2nd generation young Korean individuals, highlighting their perceptions of HPV and HPV vaccines, and their experiences with HPV vaccination.

Written Information

Intervention Type OTHER

The written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines.

K-Bot (AI Chatbot Intervention) Intervention

After completing the pre-test survey, participants from all intervention groups will receive the written information. Subsequently, they will be randomly assigned to one of the intervention groups. The K-Bot group will only interact with the chatbot via the web-based platform or KakaoTalk for 3 months.

Group Type EXPERIMENTAL

K-Bot Intervention

Intervention Type OTHER

The K-Bot intervention is a conversational and button-based artificial intelligence Chatbot that is available in both English and Korean.

Written Information

Intervention Type OTHER

The written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines.

Written Information

This group will only be exposed to written, didactic HPV education materials after the pre-test.

Group Type ACTIVE_COMPARATOR

Written Information

Intervention Type OTHER

The written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines.

Interventions

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K-Talk Intervention (Storytelling and K-Bot)

The K-Talk intervention group receives a combination of a storytelling intervention and an artificial intelligence chatbot (K-Bot) education.

Intervention Type OTHER

Storytelling Intervention

The storytelling intervention features 12 authentic stories from young Korean immigrants and Americans. Each video is about 3 minutes long and includes stories from 1st, 1.5, and 2nd generation young Korean individuals, highlighting their perceptions of HPV and HPV vaccines, and their experiences with HPV vaccination.

Intervention Type OTHER

K-Bot Intervention

The K-Bot intervention is a conversational and button-based artificial intelligence Chatbot that is available in both English and Korean.

Intervention Type OTHER

Written Information

The written information provided includes the Centers for Disease Control and Prevention's (CDC) details on HPV and HPV vaccines.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Identify as a Korean ethnic person
2. Reside in the U.S.
3. between the ages of 18 and 45
4. be able to speak or read English
5. not have been vaccinated against HPV
6. use a mobile device.

Exclusion Criteria

1. Participants who do not identify as a Korean ethnic person
2. Participants who do not reside in the U.S.
3. Participants who are not between the ages of 18 and 45.
4. Participants who cannot speak or read English.
5. Participants who have been vaccinated against HPV.
6. Participants who do not use a mobile device.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes